Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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The manufacturer has determined there is a possibility that the device may not shut off if the ablate button is released.
Model Catalog: IA-2000-S (Lot serial: >10 numbers contact mfg); Model Catalog: IA-2000-S (Lot serial: (numbers with expiration dates); Model Catalog: IA-2000-S (Lot serial: from July 2009 to Sept. 2013))